NCT06920472

Brief Summary

The goal of this observational study is to learn about the effects of psychiatric drug therapies on intra- and extra-oral sicca symptoms and salivation. The main question that it aims to answer is: Does taking psychiatric medication cause oral dryness and/or any changes on whole and minor saliva secretion? Participants taking psychiatric medication answered a 16-question questionnare, and their saliva production was measured by Periotron device and by spitting method.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
361

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2013

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
7 years until next milestone

First Submitted

Initial submission to the registry

January 15, 2025

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 9, 2025

Completed
Last Updated

May 22, 2025

Status Verified

January 1, 2025

Enrollment Period

5 years

First QC Date

January 15, 2025

Last Update Submit

May 19, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Unstimulated whole saliva flow rate (UWS)

    UWS was determined using the "spitting" method (Sreebny 2000). Whole saliva was collected for 5 minutes into a previously weighted empty cup, and then measured again after collecting the saliva. The results are in ml/min.

    through study completion, an average of 1 year

  • Minor salivary gland (MSG) secretions

    Palatal and labial MSG flow rates were measured by the Periotron 8010® (Oraflow Inc. Amytiville, USA) device with filter paper discs. The results are transferred into µl/cm2/min.

    Through study completion, an average of 1 year

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Outpatient Clinic, Department of Psychiatry and Psychotherapy and Dental Teaching Center, Semmelweis University, Budapest, Hungary

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Mental Disorders

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 15, 2025

First Posted

April 9, 2025

Study Start

January 1, 2013

Primary Completion

January 1, 2018

Study Completion

January 1, 2018

Last Updated

May 22, 2025

Record last verified: 2025-01